Uterine Fibroids Clinical Trial
Official title:
A Pilot Study to Determine the Optimal Procedure Steps to Obtain and Maintain Bilateral Uterine Artery Occlusion Using the GYNECARE GYNOCCLUDE™ Doppler Guided Uterine Artery Occlusion Device in Women With Uterine Fibroids
This pilot study has a sequential design involving three groups to ensure appropriate development and evaluation of the optimal procedural steps of the D-UAO device and to confirm that those steps are reproducible in the hands of multiple surgeons.
1. Group 1 - beginning with the use of the current instructions for use (IFU) will have
adjustments made as necessary to the D-UAO procedural steps for uterine artery
occlusion confirmed by 2/3-D Power Colour Doppler ultrasound (2/3DPD).
2. Group 2 - verify that optimal D-UAO IFU procedural steps generated in Group 1 as
confirmed by 2/3DPD.
3. Group 3 - verify that the optimal D-UAO procedural steps are reproducible in the hands
of multiple surgeons in addition to the group 1 investigators, as confirmed by 2/3DPD.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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